Tuesday, January 17, 2006
Coming Up
The California Council on Science and Technology is scheduled to release its final report on intellectual property and stem cells later today. We will have an item on it when it becomes available.
LA Times on Cirm: Disappointing, Arrogant, Unresponsive, But Promise Remains Strong
The Los Angeles Times today editorialized about the California stem cell agency, declaring that its first year was "especially disappointing."
The Southern California piece was one of three articles that surfaced this morning dealing with CIRM, including one in Oakland and another critical op-ed piece in the Baltimore Sun.
The Times said CIRM has been arrogant, unresponsive and intransigent at times.
Nonetheless, the newspaper wrote, the promise of the agency "remains strong" and could be strengthened even more with beefier standards for ethics and accountability.
Sounding a harsh note in Maryland was an opinion piece by Richard Hayes, executive director of the Center for Genetics and Society in Oakland. He focused on implications of the Hwang affair. But the article also said, concerning Proposition 71,
Reporter Rebecca Vesely of the Oakland Tribune reported on the progress of the agency and its plans for the next year. Her straight-forward piece covered much of the same ground as an article last week by Terri Somers of the San Diego Union Tribune.
The Southern California piece was one of three articles that surfaced this morning dealing with CIRM, including one in Oakland and another critical op-ed piece in the Baltimore Sun.
The Times said CIRM has been arrogant, unresponsive and intransigent at times.
Nonetheless, the newspaper wrote, the promise of the agency "remains strong" and could be strengthened even more with beefier standards for ethics and accountability.
"But the oversight committee's chairman, Robert Klein, seems to be allergic to sunshine. Much of the committee's first meeting had to be scrapped when a public-interest lawyer pointed out that it failed to meet the state's open-meeting laws. The institute's first employees were drawn from the Proposition 71 campaign and Klein's stem cell charity group, ignoring the state's civil service rules on advertising for the most qualified candidates," the newspaper wrote.
"Unfortunately, the oversight committee continues to insist that members of the working groups, including the research reviewers, do not have to publicly reveal their financial interests in stem cell research. The members of these boards will make crucial recommendations about how to spend billions of taxpayer dollars, and for the public not to know whether they stand to benefit from any particular grant is unacceptable.
"The committee does stipulate that members of the working groups reveal their conflicts of interest to the committee itself, but that is inadequate. The world of stem cell research, industry and advocacy is too incestuous for such an arrangement."
Sounding a harsh note in Maryland was an opinion piece by Richard Hayes, executive director of the Center for Genetics and Society in Oakland. He focused on implications of the Hwang affair. But the article also said, concerning Proposition 71,
"It entrusted control of the money to a new state agency dominated by the very institutions that stand to receive the research grants. It exempted the agency's most important policy committees from California's open meetings and conflict-of-interest laws.
"It failed to guarantee the safety and health of women who provide eggs for cloning research. It contained no provisions to ensure that intellectual property arrangements would benefit the people of California. And late last year, it was revealed that real estate millionaire Robert Klein, the prime author and funder of the initiative and the current chairman of the program, knowingly misrepresented its likely full cost to California voters by perhaps $1 billion.
"What's going on here is both a very old story and a very new one. The old story is the drive for fame, fortune and power and the willingness of some people - in this case, scientists and biotech entrepreneurs - to put their personal drives and ambitions above the common good.
"The new story is the immensity of what is at stake. The new human genetic technologies are giving scientists the power to change the nature of human life forever. They are being developed at breakneck speed. Neither public understanding nor governmental oversight has been able to keep up. Scientists and biotech corporations are playing to our deepest desires and fears in their effort to secure the commanding heights of the technology, the law and the market."
Reporter Rebecca Vesely of the Oakland Tribune reported on the progress of the agency and its plans for the next year. Her straight-forward piece covered much of the same ground as an article last week by Terri Somers of the San Diego Union Tribune.
Monday, January 16, 2006
CIRM and Stem Cell IP Hearings: A Cold Shoulder to the Public
Only four business days remain before the California stem cell agency takes another crack at who will benefit economically from inventions developed as the result of the $3 billion in taxpayer-supported research.
This is one of the major issues for CIRM this year. It is also the subject of separate legislative proceedings, including a proposed constitutional amendment, SCA13, by State Sen. Deborah Ortiz, D-Sacramento, that is on the floor of the State Senate. What California does this year will have an impact across the nation as other states also consider whether existing models for sharing the wealth are doing the job.
Despite the importance of the issue, no background material or proposed drafts of regulations can be found in the agenda of CIRM's Intellectual Property Task Force, as posted on the Web at the time of this writing. It simply says, "Consideration of draft IP Policy." Amazingly casual for a matter that could involve billions of dollars.
No draft of proposed regulations, much less a synopsis of what is under consideration. No explanation of whether the entire issue is on the table or whether particular subsets are to be considered. No links to previous material on the CIRM web site, which could have easily been done.
The scanty agenda of the IP task force is no exception. Generally, little or no material is available in a timely manner in advance of CIRM meetings. That makes it virtually impossible for interested parties or the public in general to prepare thoughtful comments on some very complex and important issues. All they have is three minutes at the end of the meeting to make some off-the-cuff observations. Even some members of the agency's Oversight Committee have complained about not having enough time to review agenda material because it is so tardy.
A cynic would conclude that CIRM is not interested in keeping affected parties even partially informed. Our opinion is that this is another example of the chronic cold-shoulder CIRM gives to much of its public disclosure responsibilities. The agency began business like this 12 months ago. Then it could be contributed to start-up problems. But it is past time for CIRM to fulfill its promise of adhering to highest standards of openness and transparency. Even small school districts in California do a better job of making their agenda material available online in advance of meetings. An agency that proposes to give away $3 billion must do better.
There is a new fillip to the task force's meeting, however. It will be accessible to the public in New York City at the Carlyle Hotel. One of the task force's members, former Hollywood executive Sherry Lansing, will be staying at the hotel and is going to participate via an audio hookup. The Carlyle describes itself as a "purveyor of privacy and a sanctuary of refined taste," but a CIRM official assures us that the public will be permitted to listen in on the deliberations. They also are likely to be allowed to speak during the public comment sessions.
The actual session of the task force meeting will take place at Stanford University. Other offsite locations for the 1 p.m. Jan. 23 session are in Elk Grove near Sacramento and UCLA. Specific room numbers are available in the agenda. We will carry the room number for the Carlyle when we receive it.
Additional material for the agenda may be posted by CIRM by this Friday. But for those of you who simply can’t wait, here are some links that will help to understand what CIRM is getting at. We should note that nearly all of the CIRM material comes from postings weeks after the date of the events. Moreover, even the text of CIRM's interim IP policy on training grants, approved more than a month ago is still not available online.
The transcript of the Dec. 6 meeting of the Oversight Committee. Discussion of IP begins on page 96.
The full transcript of the IP Task Force meeting Oct. 25.
The full transcript of the Nov. 22 IP Task Force meeting.
The full text of the National Research Council’s report: Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health (2006). This is recommended reading by the chairman of the IP Task Force, Ed Penhoet.
Interim report on stem cell IP by the California Council on Science and Technology.
Draft of the interim policy for IP training grants presented at the December meeting of the Oversight Committee. This was approved with some slight modifications. The text of the approved policy is not available online at the time of this writing.
A host of material from the Oct. 31 hearing by Sen. Ortiz into intellectual property, including the transcript, background on Bayh-Dole and alternative intellectual property models.
Statement and testimony by the Center for Genetics and Society on CIRM Intellectual property policies.
Statements by the Foundation of Consumer and Taxpayer Rights on CIRM intellectual property policies.
The task force is composed of persons drawn from the CIRM Oversight Committee. They are: Edward Penhoet, chair; Susan Bryant, Michael Goldberg, Sherry Lansing, Ted Love, Philip Pizzo, Francisco Prieto, John Reed, Jeff Sheehy, Oswald Steward and Janet Wright.
This is one of the major issues for CIRM this year. It is also the subject of separate legislative proceedings, including a proposed constitutional amendment, SCA13, by State Sen. Deborah Ortiz, D-Sacramento, that is on the floor of the State Senate. What California does this year will have an impact across the nation as other states also consider whether existing models for sharing the wealth are doing the job.
Despite the importance of the issue, no background material or proposed drafts of regulations can be found in the agenda of CIRM's Intellectual Property Task Force, as posted on the Web at the time of this writing. It simply says, "Consideration of draft IP Policy." Amazingly casual for a matter that could involve billions of dollars.
No draft of proposed regulations, much less a synopsis of what is under consideration. No explanation of whether the entire issue is on the table or whether particular subsets are to be considered. No links to previous material on the CIRM web site, which could have easily been done.
The scanty agenda of the IP task force is no exception. Generally, little or no material is available in a timely manner in advance of CIRM meetings. That makes it virtually impossible for interested parties or the public in general to prepare thoughtful comments on some very complex and important issues. All they have is three minutes at the end of the meeting to make some off-the-cuff observations. Even some members of the agency's Oversight Committee have complained about not having enough time to review agenda material because it is so tardy.
A cynic would conclude that CIRM is not interested in keeping affected parties even partially informed. Our opinion is that this is another example of the chronic cold-shoulder CIRM gives to much of its public disclosure responsibilities. The agency began business like this 12 months ago. Then it could be contributed to start-up problems. But it is past time for CIRM to fulfill its promise of adhering to highest standards of openness and transparency. Even small school districts in California do a better job of making their agenda material available online in advance of meetings. An agency that proposes to give away $3 billion must do better.
There is a new fillip to the task force's meeting, however. It will be accessible to the public in New York City at the Carlyle Hotel. One of the task force's members, former Hollywood executive Sherry Lansing, will be staying at the hotel and is going to participate via an audio hookup. The Carlyle describes itself as a "purveyor of privacy and a sanctuary of refined taste," but a CIRM official assures us that the public will be permitted to listen in on the deliberations. They also are likely to be allowed to speak during the public comment sessions.
The actual session of the task force meeting will take place at Stanford University. Other offsite locations for the 1 p.m. Jan. 23 session are in Elk Grove near Sacramento and UCLA. Specific room numbers are available in the agenda. We will carry the room number for the Carlyle when we receive it.
Additional material for the agenda may be posted by CIRM by this Friday. But for those of you who simply can’t wait, here are some links that will help to understand what CIRM is getting at. We should note that nearly all of the CIRM material comes from postings weeks after the date of the events. Moreover, even the text of CIRM's interim IP policy on training grants, approved more than a month ago is still not available online.
The transcript of the Dec. 6 meeting of the Oversight Committee. Discussion of IP begins on page 96.
The full transcript of the IP Task Force meeting Oct. 25.
The full transcript of the Nov. 22 IP Task Force meeting.
The full text of the National Research Council’s report: Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health (2006). This is recommended reading by the chairman of the IP Task Force, Ed Penhoet.
Interim report on stem cell IP by the California Council on Science and Technology.
Draft of the interim policy for IP training grants presented at the December meeting of the Oversight Committee. This was approved with some slight modifications. The text of the approved policy is not available online at the time of this writing.
A host of material from the Oct. 31 hearing by Sen. Ortiz into intellectual property, including the transcript, background on Bayh-Dole and alternative intellectual property models.
Statement and testimony by the Center for Genetics and Society on CIRM Intellectual property policies.
Statements by the Foundation of Consumer and Taxpayer Rights on CIRM intellectual property policies.
The task force is composed of persons drawn from the CIRM Oversight Committee. They are: Edward Penhoet, chair; Susan Bryant, Michael Goldberg, Sherry Lansing, Ted Love, Philip Pizzo, Francisco Prieto, John Reed, Jeff Sheehy, Oswald Steward and Janet Wright.
Big Stem Cell Soiree Scheduled For San Francisco
If you want to pay $1,495, you can hear California stem cell chairman Robert Klein and CIRM president Zach Hall speak at The Stem Cell Meeting March 12-14 in San Francisco.
The Stem Cell Meeting (yes, that is its title) is being produced by Burrill & Company, a San Franciso life sciences merchant bank with more than $500 million under management.
Hall and Klein are among a host of impressive folks, including two representatives from Congress and biotech business execs and researchers, scheduled to appear at the conference at the Palace Hotel.
If you are interested in being one of the top sponsors of the conference – a $45,000 privilege – it looks you are probably too late. Only three were available and those slots seem to have been sold, based on what we saw on the web site for The Stem Cell Meeting.
If you want to see Klein and Hall in action for free, check them out at the next meeting of the CIRM Oversight Committee Feb. 10 in at Stanford.
It has always struck me as odd that public officials appear at gatherings that effectively bar the public from hearing them. However, it is not an uncommon practice.
The Stem Cell Meeting (yes, that is its title) is being produced by Burrill & Company, a San Franciso life sciences merchant bank with more than $500 million under management.
Hall and Klein are among a host of impressive folks, including two representatives from Congress and biotech business execs and researchers, scheduled to appear at the conference at the Palace Hotel.
If you are interested in being one of the top sponsors of the conference – a $45,000 privilege – it looks you are probably too late. Only three were available and those slots seem to have been sold, based on what we saw on the web site for The Stem Cell Meeting.
If you want to see Klein and Hall in action for free, check them out at the next meeting of the CIRM Oversight Committee Feb. 10 in at Stanford.
It has always struck me as odd that public officials appear at gatherings that effectively bar the public from hearing them. However, it is not an uncommon practice.
New Stem Cell Links Added
We have added two new links to those carried on this blog. One is to the stem cell page of the Foundation for Taxpayer and Consumer Rights. The Santa Monica organization has a number of interesting items, including an analysis of CIRM's interim policy on intellectual property and a look at the conflicts of interest of the agency's Oversight Committee.
Also added to the links is the blog of the editors of the American Journal of Bioethics. The site is wide-ranging but includes interesting commentary and information on many of the issues confronting CIRM, although they may not relate them specifically to California. Its coverage of the Hwang scandal is especially useful.
We encourage you to take at look at the sites. Please send us suggestions for other sites that may be of interest to readers of these pages. You can do so by clicking on the word comments at the end of this item – it permits anonymous posts – or by sending a message to djensen@californiastemcellreport.com.
Also added to the links is the blog of the editors of the American Journal of Bioethics. The site is wide-ranging but includes interesting commentary and information on many of the issues confronting CIRM, although they may not relate them specifically to California. Its coverage of the Hwang scandal is especially useful.
We encourage you to take at look at the sites. Please send us suggestions for other sites that may be of interest to readers of these pages. You can do so by clicking on the word comments at the end of this item – it permits anonymous posts – or by sending a message to djensen@californiastemcellreport.com.
Sunday, January 15, 2006
The Financial Message on Stem Cell Research
For the ethically challenged, a couple of business news outlets have pointed out another good reason for high stem cell research standards – money.
Without confidence in the research and its results, both big and small investors will shy from coming up with the cash that is necessary to turn research into therapies that will cure millions and generate billions in profits.
Both Business Week Online and Bloomberg News carried pieces on the financial impact of the Korean fraud.
The headline on the Bloomberg article, prepared by Heejin Koo and William Sim, said, "Fake Stem Cell Research Work May Cost Korean Industry Billions." The article noted that Hwang's research was once estimated to be worth $34 billion to the Korean stem cell industry by 2015.
Reporter Arlene Weintraub of Business Week Online wrote that the unsettled state of stem cell research has:
The piece noted the financial importance of articles in scientific journals.
Not mentioned in the Business Week piece was Geron's performance recently during the greatest attention to the Korean scandal. Geron's share price was $9.53 on Dec. 12. Since then it has dropped to $8.52 on Jan. 13.
Weintraub also wrote that the shaky state of commercial funding of stem cell research has led to some "contortions."
Nonetheless, Lanza still has a Hopi doll of a red-tailed hawk in his office.
Without confidence in the research and its results, both big and small investors will shy from coming up with the cash that is necessary to turn research into therapies that will cure millions and generate billions in profits.
Both Business Week Online and Bloomberg News carried pieces on the financial impact of the Korean fraud.
The headline on the Bloomberg article, prepared by Heejin Koo and William Sim, said, "Fake Stem Cell Research Work May Cost Korean Industry Billions." The article noted that Hwang's research was once estimated to be worth $34 billion to the Korean stem cell industry by 2015.
Reporter Arlene Weintraub of Business Week Online wrote that the unsettled state of stem cell research has:
"...kept most venture capitalists away from anyone with the phrase 'stem cell' in their business plan. When the Korean scandal started erupting in December, shares of ACT(Advanced Cell Technology Inc.) fell 16 percent and rival Geron Corp. (NasdaqNM:GERN - News) tumbled 4 percent, despite the fact that interest in biotech was strong and the Amex Biotech Index was up 6 percent in the same period. Korea 'is just another body blow,' says ACT investor William Woodward of Santa Monica (Calif.)-based Anthem Venture Partners."
The piece noted the financial importance of articles in scientific journals.
"Geron's recent history reveals how much is at stake. On Sept. 1, the Menlo Park (Calif.) company announced that cardiac-muscle cells derived from human embryonic stem cells survived and multiplied in the hearts of rats, suggesting the cells might someday be useful for treating cardiac disease in humans. The research was published in the American Journal of Pathology. Geron's stock immediately traded up 3 percent to $11.20, on four times its normal trading volume. Such share-price bumps have allowed the company to go back to investors in a position of strength: It now has $200 million in cash and no debt."
Not mentioned in the Business Week piece was Geron's performance recently during the greatest attention to the Korean scandal. Geron's share price was $9.53 on Dec. 12. Since then it has dropped to $8.52 on Jan. 13.
Weintraub also wrote that the shaky state of commercial funding of stem cell research has led to some "contortions."
"When ACT decided to raise money by going public last year, investment bankers were so uninterested that the company opted instead to reverse-merge into a shell company that once made Hopi Indian dolls. It wasn't quite as splashy as an initial public offering, but the symbolism was perfect: The dolls represent ancestral spirits to whom the Hopis pray for rain and other gifts. New shares in hand, ACT raised $18 million from hedge funds and other risk-taking investors -- enough to carry the company into 2007. But the spirits didn't smile on this stock, which fell from a high of $7 to a recent $1.90 a share."
Nonetheless, Lanza still has a Hopi doll of a red-tailed hawk in his office.
California Stem Cell Research: Hype, Folly and Contempt?
If you believe a Washington Post editorial and an op-ed piece in the San Francisco Chronicle this weekend, California should fold up its stem cell research rather than capitulate "to "the unholy lust of scientists."
Citing the Korean scandal, self-described "professional philosopher" David S. Odeberg called for separation of science and state in his piece in the Chronicle.
Odeberg, professor of philosophy at the University of Reading, England, continued:
The Washington Post, whose editorial was carried on some California websites, also noted the pressures on scientists to overstate their results. But its main argument was that states are a "bad place" to conduct stem cell research because it would be politicized at the state level.
The Post did not mention that the reason states are seeking to fund embryonic stem cell research is because of the President's own politics and personal beliefs and the political gridlock in Congress on the issue.
Citing the Korean scandal, self-described "professional philosopher" David S. Odeberg called for separation of science and state in his piece in the Chronicle.
"How could the millions thrown at scientists be anything other than a veritable inducement to misconduct? When you combine it with the innumerable honors and awards that await the next would-be secular savior of humanity, one wonders that fraud is not even more common than it appears to be," he wrote.
Odeberg, professor of philosophy at the University of Reading, England, continued:
"It would be an act of utter folly and of contempt for honesty and integrity were Gov. Arnold Schwarzenegger's beloved California Institute for Regenerative Medicine now to go ahead."
The Washington Post, whose editorial was carried on some California websites, also noted the pressures on scientists to overstate their results. But its main argument was that states are a "bad place" to conduct stem cell research because it would be politicized at the state level.
"In California, universities already are hiring scientists and building labs, even though lawsuits have prevented the state's $3 billion funding program from issuing any grants. This kind of hype makes it particularly difficult for states, which do little basic research funding, to judge the value of individual stem cell research projects."
The Post did not mention that the reason states are seeking to fund embryonic stem cell research is because of the President's own politics and personal beliefs and the political gridlock in Congress on the issue.
Friday, January 13, 2006
Bioethics Blog Disagrees with CIRM Exec
The editors blog of the American Journal of Bioethics does not agree with the position of Zach Hall, president of CIRM, that peer review can prevent a Korean-type scandal in California.
Here's the key quote:
Here's the key quote:
"This from the guy who is giving out the money. Oversight is the key to giving the money out responsibly. It is one of the reasons why we should give government funding in the first place. California has become the standard-bearer for state-based biotechnology research funding…."
This would be okay, "but not if the standard-bearer claims that fraud is best prevented by peer review."
Chronicle: CIRM Needs Careful Regulation
The San Francisco Chronicle said today the Korean stem cell scandal is a “cautionary tale” that shows that the California stem cell agency needs additional public regulation.
The editorial in today’s paper said:
The editorial continued:
The editorial in today’s paper said:
"What is to prevent similar fraud and ethical lapses from happening here in California, where voters agreed to spend $3 billion on stem-cell research?
"'Scientists,' responded Zach Hall, president of the California Institute for Regenerative Medicine, the funding entity created by Prop. 71. Warning that every industry has the potential for an Enron, Hall touted the American system of peer review as the best way to expose rogue scientists and bad science and to keep research-funding decisions apart from undue political, religious or geographic influences. 'What will not stop this from happening is government oversight,' he said.
"In a world of 'pure' science, maybe. But stem-cell research is, at this point, anything but pure. Scientists rail about the 'political'interference in their work by the religious-right aligned Bush administration, but what was the campaign launched by the stem-cell research proponents to sell the stem-cell bonds, if not political? With business and political capital -- not to mention the state's image as a technological innovator -- on the line, the stem-cell institute needs oversight, both regulatory and scientific."
The editorial continued:
"Questions remain about the sourcing of the human eggs and about which avenues of research are best pursued with the taxpayers' money. Would voters embrace research that might require hundreds of human eggs to produce a therapy for a single person? If these rules are adopted, who enforces them? Are there punishments for infractions?
"These matters of great public concern should be subject to government regulation -- especially when taxpayers are picking up the multi-billion-dollar tab for this research."
New Money-Raising Effort at CIRM
The California stem cell agency began a new, $2 million fundraising drive yesterday to pay for such things as a national conference in May on the medical risks of human egg donations and how to reduce them, according to the San Diego Union Tribune.
Reporter Terri Somers quoted Zach Hall, president of CIRM, as saying the effort is aimed at financing “nongrant” scientific activity. Hall also said the agency is now focusing on creating a structure that will allow it to move quickly once litigation against it is resolved.
Somers wrote that the “image of a torrent worries” Jesse Reynolds of the Center for Genetics and Society.
The latest fundraising effort is in addition to the $50 million effort to sell bond anticipation notes.
Reporter Terri Somers quoted Zach Hall, president of CIRM, as saying the effort is aimed at financing “nongrant” scientific activity. Hall also said the agency is now focusing on creating a structure that will allow it to move quickly once litigation against it is resolved.
"We want to hit the ground running once the money comes in. Rather than sending out a slow and gradual stream of funding, the plan now is to let a torrent of funding flow like waters set free from a sluice gate."
Somers wrote that the “image of a torrent worries” Jesse Reynolds of the Center for Genetics and Society.
“He wondered if there was enough good science to warrant such funding at this time. But he was also somewhat comforted by the plan.“Originally, the institute's leaders talked about making their first grants last May, which Reynolds said was ludicrous. To hear them now talking about having their organizational infrastructure in place first sounds better, he said.”
The latest fundraising effort is in addition to the $50 million effort to sell bond anticipation notes.
Thursday, January 12, 2006
CIRM, Cibelli, Korea and The Bee
An official of the California stem cell agency is taking issue with a Sacramento Bee editorial that indicated that CIRM was not taking the Korean scandal sufficiently seriously.
The editorial referred to a meeting Dec. 1 of the Standards Working Group. At that time, the Hwang affair had not surfaced completely, but it was evident that extremely serious problems existed.
Bernard Lo, co-chair of the group and director of the UC San Francisco Program in Medical Ethics, said in his letter:
One of the members of the standards group is Jose Cibelli, a reknown Michigan State University scientist. He is also a co-author of the fraudulent March 2004 paper by Hwang that reported the first-ever closed human stem-cell line. Cibelli was present at the December meeting and participated in the discussions.
Queried by the California Stem Cell Report, a spokeswoman for Michigan State said,
The editorial referred to a meeting Dec. 1 of the Standards Working Group. At that time, the Hwang affair had not surfaced completely, but it was evident that extremely serious problems existed.
Bernard Lo, co-chair of the group and director of the UC San Francisco Program in Medical Ethics, said in his letter:
"Contrary to the assertion that we went 'out of our way' to avoid discussion of Hwang's difficulties, a review of the written record of the Dec. 1 meeting of this committee, posted on Dec. 12, demonstrates that the Korean developments were the catalysts for extensive discussion on egg donation. The result was numerous recommendations to prohibit the practices that sparked the Korean controversy. Further, we have developed enforceable rules that exceed existing state and federal guidelines to ensure that research is conducted safely and ethically."A search of the 263-page transcript shows that the word "Hwang" was mentioned twice and "Korea" or variations of it popped up eight times. Obviously such a simple count does not measure the quality of the discussion. Korea did trigger some exchanges, and the group also discussed a wide range of ethical subjects, including the value of a woman's eggs.
One of the members of the standards group is Jose Cibelli, a reknown Michigan State University scientist. He is also a co-author of the fraudulent March 2004 paper by Hwang that reported the first-ever closed human stem-cell line. Cibelli was present at the December meeting and participated in the discussions.
Queried by the California Stem Cell Report, a spokeswoman for Michigan State said,
"Michigan State University is conducting an investigation into Dr. Cibelli’s role on the '04 paper, where he is listed as a co-author. The investigation was started at Dr. Cibelli’s request. Given the investigation, there won’t be any comment available. For more information on the process, see: http://www.msu.edu/unit/vprgs/level2/conductres.htmWe should note that CIRM officials have stated in the past that scientists are often reluctant to criticize their peers' work in public. It is one of their justifications for maintaining closed door reviews of grant applications.
California Pushing Ahead with Cloning ESC
From San Diego, where stem cells meet the surf(see "Science of Surfing"), comes a couple of stories dealing with the California stem cell agency and some of the California fallout from the Korean scandal.
Reporter Terri Somers of the San Diego Union-Tribune wrote in some detail about the plans of California scientists to jump into the field of cloning human embryonic stem cells. It was that effort in Korea that turned out to be frauduent.
But scientists in California aren't giving up, and they hope to secure funds from the California stem cell agency to pursue their work.
Somers wrote:
Reporter Terri Somers of the San Diego Union-Tribune wrote in some detail about the plans of California scientists to jump into the field of cloning human embryonic stem cells. It was that effort in Korea that turned out to be frauduent.
But scientists in California aren't giving up, and they hope to secure funds from the California stem cell agency to pursue their work.
Somers wrote:
Also weighing in from San Diego was Richard Murphy, president of the Salk Institute and a member of the Oversight Committee for CIRM. His op-ed piece in the San Diego paper was a reprise of CIRM one year later. He said:"My guess is that just about everyone who has a stem cell research center is going to jump into this," said Jeanne Loring, a stem cell researcher at the Burnham Institute in La Jolla.
"All of the California research institutes stressed that in moving forward, they will follow the latest and strictest ethical guidelines to avoid the lapses uncovered in South Korea."
"I am often asked when California's stem cell research is going to get off the ground. The answer is, we don't know. At the moment, state-supported human embryonic stem cell research is at a standstill, tied up in the courts by research opponents who are arguing that Proposition 71 is unconstitutional.
"But these opponents have not succeeded in preventing CIRM's employees from creating an impressive state-supported stem cell institute that is ready to spring into action once the monies flow. Government agencies are often targets for criticism, but Californians are getting more than their money's worth from this one."
Wednesday, January 11, 2006
IP, IP, IP and More IP
The website of the Health Committee of the California state Senate is awash in intellectual property – that is, information dealing with the multimillion dollar questions of who profits from research funded by the California stem cell agency.
The Health Committee is chaired by Sen. Deborah Ortiz, D-Sacramento, who is carrying a proposed constitutional amendment concerning IP and CIRM. So much of the information comes from her hearing last Oct. 31, including a transcript of the proceedings.
But there are additional links to to background information at the University of California, the NIH, the California Council on Science and Technology and alternative IP models. Also included is information from last March's hearing into implementation of Prop. 71 and a hearing on the measure prior to its passage in November 2004.
If you want to know what is going on with IP issues and CIRM, this is one of the places you need to check out.
The Health Committee is chaired by Sen. Deborah Ortiz, D-Sacramento, who is carrying a proposed constitutional amendment concerning IP and CIRM. So much of the information comes from her hearing last Oct. 31, including a transcript of the proceedings.
But there are additional links to to background information at the University of California, the NIH, the California Council on Science and Technology and alternative IP models. Also included is information from last March's hearing into implementation of Prop. 71 and a hearing on the measure prior to its passage in November 2004.
If you want to know what is going on with IP issues and CIRM, this is one of the places you need to check out.
Tuesday, January 10, 2006
Vaccine Advisory
For those of you who have been looking for the "sunshine vaccine" item, it has been reposted a couple of items below. It was inadvertently removed during a feeble attempt to fix some html coding errors.
Hwang Reaction: Research Needs More Care
In the first of what is likely to be a series of comments about the impact of the Korean stem cell fraud findings, a top Stanford researcher says they show that researchers must "work more deliberately."
Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine, released a statement that included the following:
Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine, released a statement that included the following:
Weissman called the Korean scandal a "personal tragedy" for Hwang and his scientific colleagues."With the dollars provided by California's Proposition 71, Stanford intends to recruit scientists who will find ways to do nuclear transfer research, first in animal models and then with human cells, using the safest and most effective methods.
"The Stanford Institute for Stem Cell Biology and Regenerative Medicine is committed to advancing the field through the creation of new stem cell lines, research to further understand stem cell biology and the development of treatments for disease. Proposition 71 will play a significant role in helping Stanford researchers as well as other California institutions achieve the full therapeutic potential of stem cells."
"While the announcement is a disappointing setback for nuclear transfer stem cell research, we are all making significant progress in the fields of adult tissue stem cell research, embryonic stem cell research and cancer/leukemia stem cell research. We must work more deliberately on nuclear transfer stem cell research, but we must go forward ethically and responsibly, as the future potential applications for the diagnosis and treatment of human diseases using these tools is so great," Weissman said.
CIRM Promises Open Search on General Counsel
After we posted the item below, the California stem cell agency emailed the following comment on Bedford's position at CIRM.
"CIRM will engage in a full and open recruitment process for the position of General Counsel when our funds become available."
"CIRM will engage in a full and open recruitment process for the position of General Counsel when our funds become available."
Update on CIRM's General Counsel: An Orrick Connection
The California stem cell agency may have found the man who will be its new general counsel once the money really starts rolling in.
He is Daniel R. Bedford who is working fulltime pro bono at CIRM while he winds up affairs at Orrick, Herrington & Sutcliffe LLP of San Francisco.
It is our understanding that Bedford will fill the general counsel slot at a later point, but neither he nor CIRM would confirm that. Currently CIRM has put a hold on new hiring because of its budget crunch.
Bedford is assisting "CIRM generally on its many legal matters," says Nicole Pagano, a spokeswoman for CIRM. "At the moment most of his time is devoted to helping CIRM put together its Grants Administration Policy and advising on internal governance questions."
According to Orrick's web site, Bedford focused his practice on complex asset-based and lease financing, with an emphasis on agribusiness, domestic and international project financing, and tax-advantaged leasing."
His work has included representation of John Hancock Life Insurance in areas concerning equity and debt direct private placements. Other clients included public transit districts and Banc of America Securities. Much of his work involved various kinds of debt, which would seem to be a good fit with the needs of CIRM in connection with the issuance of state bonds.
Bedford has also participated in complex negotiations for natural gas pipelines involving government agencies, both in the US and involving Argentina, Chile, Brazil and Bolivia. Orrick's site did not list any involvement with biotech firms.
Orrick is bond counsel to California, but Orrick's site does not show any work by Bedford for the state.
Bedford received a B.S., M.B.A. and J.D. from Stanford University, where he was a member of Phi Beta Kappa.
He is Daniel R. Bedford who is working fulltime pro bono at CIRM while he winds up affairs at Orrick, Herrington & Sutcliffe LLP of San Francisco.
It is our understanding that Bedford will fill the general counsel slot at a later point, but neither he nor CIRM would confirm that. Currently CIRM has put a hold on new hiring because of its budget crunch.
Bedford is assisting "CIRM generally on its many legal matters," says Nicole Pagano, a spokeswoman for CIRM. "At the moment most of his time is devoted to helping CIRM put together its Grants Administration Policy and advising on internal governance questions."
According to Orrick's web site, Bedford focused his practice on complex asset-based and lease financing, with an emphasis on agribusiness, domestic and international project financing, and tax-advantaged leasing."
His work has included representation of John Hancock Life Insurance in areas concerning equity and debt direct private placements. Other clients included public transit districts and Banc of America Securities. Much of his work involved various kinds of debt, which would seem to be a good fit with the needs of CIRM in connection with the issuance of state bonds.
Bedford has also participated in complex negotiations for natural gas pipelines involving government agencies, both in the US and involving Argentina, Chile, Brazil and Bolivia. Orrick's site did not list any involvement with biotech firms.
Orrick is bond counsel to California, but Orrick's site does not show any work by Bedford for the state.
Bedford received a B.S., M.B.A. and J.D. from Stanford University, where he was a member of Phi Beta Kappa.
Monday, January 09, 2006
Time for a Stem Cell Sunshine Vaccine
The international scientific conference that was sponsored last fall by the California stem cell agency had an interesting sidelight that is now surfacing in the Korean research scandal.
It was in San Francisco at the time of the conference that Gerald Schatten, the University of Pittsburgh scientist who co-authored the fraudulent Korean stem cell paper, met with Hwang Woo-suk and asked for a 50 percent share of the patent, according to Merrill Goozner, director of the Integrity in Science project at the Center for Science in the Public Interest.
Hwang rejected Schatten's request. About six weeks later Schatten publicly broke with Hwang, helping to set in motion a string of events that culminated in Hwang's disgrace.
The rejected request by Schatten has been reported previously (Nov. 29), although we had not seen the location of the meeting. But as Goozner notes, it has received little notice in American media. Goozner also points to a story on Saturday by reporter Jennifer Bails of the Pittsburgh Tribune-Review, who wrote that Schatten "is seeking to patent technology to create embryonic stem cells without crediting his now-estranged colleagues in South Korea."
The 50-percent request is not the only allegation about Schatten that has received little scrutiny. Totally overlooked by most newspapers was a report Dec. 16 by Associated Press writer Paul Elias. He wrote that Schatten, who was listed as "senior author" on the Hwang paper, could also become a victim of the Korean scandal.
"At the very least, Schatten faces a formal reprimand once an internal school investigation is concluded," Elias said.
He quoted Arthur Levine, dean of Pitt medical school, as saying:
Other allegations concerning Schatten have also received short shrift in this country. They include aKorean statement that Hwang rejected Schatten's request to serve as chair of the once-vaunted World Stem Cell Hub. Hwang also reportedly rejected a Schatten request for a payment of $200,000 to help start the US operations of the World Stem Cell Hub, according to Digital Chosun.
Schatten and Pitt have generally not responded to the allegations. Pitt is conducting its inquiry behind closed doors, a process Goozner called outrageous.
Bails wrote:
In his blog, Goozner wrote that Hwang was also attempting to patent the same research without mentioning Schatten.
Aside from the San Francisco meeting between Hwang and Schatten, what does all this have to do with CIRM? Much of it goes right to the point of the hottest issues before CIRM this year. The agency, as well as the legislature, is in the midst of wrestling with the question of ownership of state-funded research results and sharing access to those results. The fallout is likely to build support for more sharing rather than less. The Korean scandal also reminds us that the stakes are huge and people are tempted by riches and fame. It tells us that more disclosure is better than less about the economic interests of those associated with the $3 billion California effort. Call disclosure a kind of sunshine vaccine. Without some protections such as could be provided by a pending state constitutional amendment, the CIRM program would not likely survive a scandal of even a fraction of the magnitude of the Korean affair.
It was in San Francisco at the time of the conference that Gerald Schatten, the University of Pittsburgh scientist who co-authored the fraudulent Korean stem cell paper, met with Hwang Woo-suk and asked for a 50 percent share of the patent, according to Merrill Goozner, director of the Integrity in Science project at the Center for Science in the Public Interest.
Hwang rejected Schatten's request. About six weeks later Schatten publicly broke with Hwang, helping to set in motion a string of events that culminated in Hwang's disgrace.
The rejected request by Schatten has been reported previously (Nov. 29), although we had not seen the location of the meeting. But as Goozner notes, it has received little notice in American media. Goozner also points to a story on Saturday by reporter Jennifer Bails of the Pittsburgh Tribune-Review, who wrote that Schatten "is seeking to patent technology to create embryonic stem cells without crediting his now-estranged colleagues in South Korea."
The 50-percent request is not the only allegation about Schatten that has received little scrutiny. Totally overlooked by most newspapers was a report Dec. 16 by Associated Press writer Paul Elias. He wrote that Schatten, who was listed as "senior author" on the Hwang paper, could also become a victim of the Korean scandal.
"At the very least, Schatten faces a formal reprimand once an internal school investigation is concluded," Elias said.
He quoted Arthur Levine, dean of Pitt medical school, as saying:
"One should only be the senior author of a scientific paper when one has prepared and was responsible for all the data in that paper. It also implies the senior author is the chief of the lab where the experiment took place."
Other allegations concerning Schatten have also received short shrift in this country. They include aKorean statement that Hwang rejected Schatten's request to serve as chair of the once-vaunted World Stem Cell Hub. Hwang also reportedly rejected a Schatten request for a payment of $200,000 to help start the US operations of the World Stem Cell Hub, according to Digital Chosun.
Schatten and Pitt have generally not responded to the allegations. Pitt is conducting its inquiry behind closed doors, a process Goozner called outrageous.
Bails wrote:
"The rush to file biomedical patents for early-stage technologies creates roadblocks to research that do a disservice to the public by requiring scientists to dish out licensing money whenever they have an idea that might be worth pursuing, Goozner said.
"'It sets up arbitrary financial roadblocks to research,' Goozner said. 'We need new systems that make these technologies open to all scientists at the lowest possible price, and when the government funds them, it should be the government insisting that's how they are managed.'"
In his blog, Goozner wrote that Hwang was also attempting to patent the same research without mentioning Schatten.
"Ownership disputes over key stem cell patents have been simmering since the field emerged in the late 1990s. The University of Wisconsin, whose researcher James Thomson used Geron Corp. funding to isolate the first embryonic stem cell lines, charges $100,000 to commercial concerns and $5,000 to academics for access to those lines. It also granted Geron exclusive rights to pursue therapies in the most promising fields. Last May, San Diego-based stem cell researcher Jeanne Loring told Nature magazine her start-up firm collapsed because it couldn’t get access to the Wisconsin patents at reasonable rates," Goozner said.In the case of Hwang, however, one wonders why someone would want to patent bogus research results.
Aside from the San Francisco meeting between Hwang and Schatten, what does all this have to do with CIRM? Much of it goes right to the point of the hottest issues before CIRM this year. The agency, as well as the legislature, is in the midst of wrestling with the question of ownership of state-funded research results and sharing access to those results. The fallout is likely to build support for more sharing rather than less. The Korean scandal also reminds us that the stakes are huge and people are tempted by riches and fame. It tells us that more disclosure is better than less about the economic interests of those associated with the $3 billion California effort. Call disclosure a kind of sunshine vaccine. Without some protections such as could be provided by a pending state constitutional amendment, the CIRM program would not likely survive a scandal of even a fraction of the magnitude of the Korean affair.
Why Whales Migrate
When two U.S. scientists decided to take their research to Singapore last fall, one Stanford stem cell researcher called it a "loss for America."
The two are Neal Copeland and Nancy Jenkins. They left the National Institute of Cancer in Maryland and rejected a pitch from Stanford as well before deciding to depart for Asia.
They said they would have moved to California if funds were available from the state's stem cell agency. Writers Sara Webb and Mia Shanley of Reuters recently explored more of the couple's reasons for leaving the Home of the Free and the Land of the Brave. They included "restrictions on government funding for stem cell research, shrivelling grants and curbs on commercial spin-offs from their work such as consulting and other fees," the scientists told Reuters.
The news agency reported:
Singapore is currently engaged in a major recruitment drive to attract top scientists – "whales"-- as part of a multi-billion dollar biomedical research effort. Last fall reporter Lisa Krieger of the San Jose Mercury News wrote about the couple's decision. Irving Weissman, director of Stanford's Institute for Cancer/Stem Cell Biology and Medicine, told Krieger:
The two are Neal Copeland and Nancy Jenkins. They left the National Institute of Cancer in Maryland and rejected a pitch from Stanford as well before deciding to depart for Asia.
They said they would have moved to California if funds were available from the state's stem cell agency. Writers Sara Webb and Mia Shanley of Reuters recently explored more of the couple's reasons for leaving the Home of the Free and the Land of the Brave. They included "restrictions on government funding for stem cell research, shrivelling grants and curbs on commercial spin-offs from their work such as consulting and other fees," the scientists told Reuters.
The news agency reported:
"'The amount of money going towards research is going down. It doesn't have a high priority (in the United States). In Singapore it does," said Copeland, adding that they would like to exploit some of their Singapore-funded research commercially.
"Copeland and Jenkins said they had been won over by Singapore's scientific freedom, deep pockets and interest in commercial applications, at a time when the U.S. government's National Cancer Institute in Maryland -- where they worked for 20 years -- began a clamp down on consulting work by its scientists."
The story continued:
"In an era where funding is critical -- even a microscope can cost half a million dollars -- wealthy Singapore has the money.
"That, say scientists, has been Singapore's attraction, along with speedy grant approvals and lack of burdensome paperwork.
"'We don't want to spend the rest of our lives writing grants,' said Copeland, adding that Singapore's quick access to funding was key. The couple's colony of 20,000 mice costs some $1 million a year to maintain."
Singapore is currently engaged in a major recruitment drive to attract top scientists – "whales"-- as part of a multi-billion dollar biomedical research effort. Last fall reporter Lisa Krieger of the San Jose Mercury News wrote about the couple's decision. Irving Weissman, director of Stanford's Institute for Cancer/Stem Cell Biology and Medicine, told Krieger:
"'It is a loss for Stanford and a loss for America,' Weissman said. 'Without a doubt, they are the best people I know to find out which genes are altered to cause cancer.
"'When they do their work, it will be for Singapore,' he said. 'They'll conduct their clinical trials in Singapore. The first place their work will be patented and used will be Singapore.'"
Sunday, January 08, 2006
Studying the Science of Surfing
It's just like science say the biotech "dudes" who combine business and surfing in the Pacific Ocean near San Diego.
"In San Diego's booming biomedical industry, opportunity tends to come in waves — the kind found at La Jolla Shores or Black's Beach or Scripps Pier. Surfing has become a way to make contacts, get face time with the boss and arrange deals," wrote reporter Denise Gellene in the Los Angeles Times on Sunday.
They call them "board" meetings and report that "it's where the best business gets done." One surfer, Steve Mayfield, named his company, Rincon Pharmaceuticals Inc., after a surfing spot somewhat farther north on the California coast. Mayfield is also an associate professor of cell biology at the Scripps Research Institute.
Laura Shawver, chief executive of Phenomix Corp., said riding the waves has something in common with biotech.
"This is just like science. You must be very persistent. You can have spectacular wipeouts followed by the high of your life. And you are always looking for the next one."
We should report that we surfed a spot in La Jolla early in December but did not see any major stem cell breakthroughs or deals being hatched. But again it is about being in the right place at the right time.
"In San Diego's booming biomedical industry, opportunity tends to come in waves — the kind found at La Jolla Shores or Black's Beach or Scripps Pier. Surfing has become a way to make contacts, get face time with the boss and arrange deals," wrote reporter Denise Gellene in the Los Angeles Times on Sunday.
They call them "board" meetings and report that "it's where the best business gets done." One surfer, Steve Mayfield, named his company, Rincon Pharmaceuticals Inc., after a surfing spot somewhat farther north on the California coast. Mayfield is also an associate professor of cell biology at the Scripps Research Institute.
Laura Shawver, chief executive of Phenomix Corp., said riding the waves has something in common with biotech.
"This is just like science. You must be very persistent. You can have spectacular wipeouts followed by the high of your life. And you are always looking for the next one."
We should report that we surfed a spot in La Jolla early in December but did not see any major stem cell breakthroughs or deals being hatched. But again it is about being in the right place at the right time.
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